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Abstract:

An intra-oral container comprises at least one region for accommodating
an electronic device, wherein the container is curved and is shaped to be
fitted in at least a portion of a space formed by a lower jaw of a
recipient, wherein at least a portion of the container is displaceable
for enabling compression of the container during insertion thereof in
said space.

Claims:

1. An intra-oral container comprising at least one region for
accommodating an electronic device, wherein the container is curved and
is shaped to be fitted in at least a portion of a space formed by a lower
jaw of a recipient, wherein a portion of the container is displaceable
for enabling compression of the container during insertion thereof in
said space.

2. A container according to claim 1, wherein the container is
substantially U-shaped, O-shaped or arc-shaped.

3. A container according to claim 2, wherein the container is U-shaped
having two legs and a base, wherein one or two legs are displaceable with
respect to the base.

4. A container according to claim 2, wherein the container is U-shaped,
the container further comprising a fixating member arranged between the
legs and being formed of a top layer of material superposed on a bottom
layer of material having chamber therebetween, wherein the bottom layer
is perforated.

5. A container according to claim 3, wherein the at least one leg is
resilient or wherein container is molded from a resilient material.

6. A container according to claim 1, wherein the container is adapted to
exhibit a lateral force on the lower jaw when positioned in said space.

7. A container according to claim 1, wherein the container is
substantially three-dimensional, a curvature of an outer surface of the
container substantially matching a curvature of the space formed by the
lower jaw.

8. A container according to claim 1, wherein at least the outer surface
of the container configured to come into contact with the lower jaw
comprises a soft material.

9. A container according to claim 8, wherein the soft material is
thermoplastic.

10. A container according to claim 8, wherein the soft material comprises
a bag provided with a filling, a shape of the bag being vacuum-shapeable.

11. A container according to claim 1, wherein the container is provided
with a projection, cavity or a rim for enabling handling of the
container.

12. A container according to claim 1, further comprising at least one
cavity for enabling positioning of the container using vacuum suction.

13. A container according to claim 1, further comprising a safety element
for enabling an acute removal of the container from said space, or for
indicating a position of the container and/or a condition of the
electronic device.

14. A container according to claim 1, comprising an electronic device.

15. A container according to claim 14, wherein the electronic device is
selected from a group consisting of: a monitoring device, a stimulating
device, a saliva pumping unit, and a camera.

Description:

FIELD OF THE INVENTION

[0001] The invention relates to an intra-oral container for accommodating
an electronic device.

BACKGROUND

[0002] In a clinical set-up, for example during an intensive care of a
patient, there is a need for non-invasive measurements and monitoring of
physiological parameters of the patient, which provides necessary
insights in a medical status of the patient.

[0003] An embodiment of the intra-oral container as is set forth in the
opening paragraph is known from US2009210032. The known device is
arranged to accommodate a suitable electronic device, which can be used,
for example, for monitoring, diagnosing or treating local and/or systemic
diseases and conditions of humans or animals.

[0004] The known container is arranged to be positioned inside the mouth
of the recipient externally to the teeth. In order to enable a positional
stability of the known container it comprises a projection conceived to
engage with a mole of the recipient.

[0005] It is a disadvantage of the known container that it is not
convenient for use for purposes of prolonged monitoring, for example in
an intensive care department. It is a further disadvantage of the known
container that it has to be fixed to a molar of the recipient thereby
possibly inducing tissue damage to a gum and/or to enamel.

[0006] A further embodiment of the container as is set forth in the
opening paragraph is known from JP7246191. The known container is
arranged to engage with the upper teeth of the recipient at a frontal
region and at two lateral regions thereof for enabling positional
consistency of the container and an electronic device associated with it.

[0007] It is a disadvantage of the known container that it may be not
convenient for durable measurements as a substantially massive container
has to be positioned adjacent to the palate, which may obstruct an air
path during inhalation and exhalation. In addition, due to the fact that
the known container is conceived to engage the teeth along a substantial
surface area hygienic problems may occur due to obstruction of these
teeth for cleaning.

[0008] A still further embodiment of the container as is set forth in the
opening paragraph is known from US 2003154990. The known container is
arranged as a bite, like one used by sportsmen, wherein both the upper
teeth and the lower teeth have to engage the container and to
substantially constantly exhibit a biting force on it.

[0009] It is a disadvantage of the known container that it is not suitable
for being used for prolonged monitoring, especially during intensive care
as the teeth have to be constantly engaged with the bite causing the
mouth to be kept shut. Clearly, such posture may not be kept for several
hours without interruption.

SUMMARY

[0010] It is an object of this disclosure to provide a container for
accommodating an electronic device for enabling intra-oral monitoring or
therapy, wherein such container is user friendly, easy to handle and is
suitable to be used during prolonged monitoring, especially under the
intensive care conditions.

[0011] To this end, an intra-oral container comprises at least one region
for accommodating an electronic device, wherein the container is curved
and is shaped to be fitted in at least a portion of a space formed by a
lower jaw of a recipient, wherein a portion of the container is
displaceable for enabling compression of the container during insertion
thereof in said space.

[0012] The insight is based on the fact that during clinical studies it
has occurred that the lower portion of the oral cavity, i.e. an
intro-oral space inside the lower jaw is particularly suitable for
allowing a durable dwelling of a monitoring device. This space has an
advantage that it is easily accessible and that a device positioned in
this cavity does not interfere with a physiologic activity of a
recipient, it does not obstruct breathing, it can be left in the oral
cavity during eating and it does not hamper mouth hygiene.

[0013] When such container is used for enabling durable monitoring
critical processes which may take place in the recipient, for example, in
a patient being under intensive care, the patient may be readily
monitored improving quality of the medical care.

[0014] Preferably, the region arranged for accommodating an electronic
device comprises a cavity wherein a suitable device may be housed. The
device may be positioned inside this cavity before use and may be
properly sealed. Alternatively, the region may be implemented as a
suitable compartment for accommodating an electronic device. Preferred
embodiments of the electronic device relate to a monitoring device, such
as a temperature or a CO2 sensor, a stimulating device comprising
electrodes or a micro-pump adapted to collect a suitable volume of
saliva, for example 0.1 ml, for further analysis. The electronic device
may also relate to a microscopic camera. The electronic device may be
suitably sealed for protecting its integrity while dwelling in the space
of a lower jaw of the recipient.

[0015] It is possible that both the container and the electronic device
are reusable or disposable. It is also possible that the container is
disposable and that the electronic device is reusable.

[0016] Preferably, the container is U-shaped, arc-shaped or O-shaped.

[0017] It will be appreciated that for different purposes differently
shaped containers may be required. For example, for an application
wherein one or two devices are to be accommodated by the container an
arc-shaped container may suffice, wherein for an application wherein a
greater plurality of devices may be required a U-shaped or an O-shaped
container may be required.

[0018] It will be appreciated that it is either possible to manufacture a
set of suitable shapes, wherein a smaller one may correspond to an
infant, a medium to an average value for females and a large
corresponding to an average value for males. It is also possible to
provide a differently arranged set of shapes, like a kit comprising an
arc, a U-shape and an O-shape, which may be selectable on demand.

[0019] It will be further appreciated that the container is arranged for
allowing at least a partial compression thereof for inserting into the
cavity formed by the lower jaw. Accordingly, an arc-shaped container may
be formed such that a radius of the arc is reduced during insertion. The
O-shaped container may be adapted to allow compression of the O-shape in
one or more directions during insertion. It will be further appreciated
that the O-shape may relate to a circular or an oval container. The
U-shaped container is preferably adapted to allow compression of the legs
of the U-shape with respect to the base of the U-shape, preferably
towards a symmetry direction of the U-shape. Accordingly, by providing
for the compression of the container handling thereof during insertion
into the oral cavity is substantially improved. Expansion of the
container against the inner side of the lower jaw enables positioning and
fixation of said container.

[0020] For example, a U-shape may be provided with one or two displaceable
legs, in the latter case handling of the U-shape is substantially
improved. Preferably, the leg of the U-shape is displaced towards a
symmetry axis of the U-shape resulting in the U-shape compressed as a
whole which simplifies its insertion into the mouth of a recipient and
enables a suitable fixed positioning inside the lower jaw.

[0021] It will be appreciated that the term `lower jaw` relates to both
the bony structures and the soft tissue as usually present in a
three-dimensional space under the tongue. It will be further appreciated
that it is not necessary that all teeth are present in the jaw for
implementation.

[0022] In a still further embodiment of the container, the container is
adapted to exhibit a lateral force on the lower jaw when positioned in
said space. For example, the legs of the U-shape may be dimensioned to
allow the U-shape to firmly dwell in the lower jaw.

[0023] It is found that it is advantageous to shape and to dimension the
container so that it, after being placed in the space inside the lower
jaw, substantially firmly abuts against the lower jaw. For example, it
may be advantageous to provide the U-shape with slightly diverging legs
opting that at least the distal portion of the leg exhibits a lateral
force against the lower jaw.

[0024] In an embodiment of the container, both legs of the U-shape are
displaceable. It is found that when both legs are displaceable a better
compression of the U-shape may be achieved leading to a further
improvement of the handling properties of the container.

[0025] It is found to be particularly advantageous to provide the U-shape
with a length between 25-30 mm (i.e. the distance between the base of the
U-shape and the distal portions of the legs). A width of the U-shape may
be set to a value in the range of 32-36 mm, when at rest. Preferably, a
width of the compressed U-shape is 20-25 mm. It will be appreciated that
the dimensions of the O-shaped or an arc-shaped containers are similar.

[0026] In a still further embodiment there may be a section of material
between the outer parts of the container, comprising a thin, flat,
flexible material with a closed top layer and a perforated bottom layer
enwrapping a space which, when vacuum is applied to it, will suck against
the bottom of the oral cavity, preventing the container to move.

[0027] In a still further embodiment of the container, the container is
substantially three-dimensional, a curvature of an outer surface of the
container substantially matching a curvature of the space formed by the
lower jaw.

[0028] It is found to be particularly advantageous to provide the
container with a predetermined outer slope which substantially matches
the slope of the lower jaw. The combination of said slope with the
capability to expand the container against the inner lower jaw, will
substantially improve the firm positioning of the container.

[0029] In a still further embodiment of the container at least the outer
surface of the container conceived to come into contact with the lower
jaw comprises a soft material.

[0030] It is found that in order to prevent soft tissue damage and to
improve positioning of the container inside the lower jaw, at least a
surface conceived to come into contact with a tissue of the lower jaw
(soft tissue or bony tissue) may be made soft. Preferably, the soft
material is thermoplastic. It is found to be advantageous to provide at
least a portion of the container conceived to contact with the lower jaw
of the recipient with the soft material, which may be thermosettable when
heated to about 36 degrees Celsius. It will be appreciated that a person
skilled in the art will know which class of materials may meet these
criteria. It will be further appreciated that it is not necessary that
the thermosetting material hardens completely, as this may introduce some
discomfort to the soft tissues of the oral cavity. It will be understood,
that the container may be manufactured entirely from a substantially soft
and, preferably, flexible material. Alternatively, only the surface
conceived to abut the lower jaw may be manufactured form a soft and,
preferably, flexible material. Suitable soft materials comprise but are
not limited to biocompatible resins, foams, gels or the like.

[0031] In a still further embodiment of the container the soft material is
shapeable.

[0032] It is found to be particularly advantageous to provide the surface
of the container, for example, the U-shape conceived to come into contact
with the lower jaw from a soft, shapeable material. This has an advantage
that the container may three-dimensionally fit into the lower jaw
substantially without areas which are over-pressured and areas which have
no contact with the jaw. Preferably, the soft material comprises a bag
provided with a filling, a shape of the bag being vacuum-shapeable. Those
skilled in the art readily appreciate that a suitable bag, for example,
filled with foam particles may be readily shaped in three dimensions
using vacuum.

[0033] In a still further embodiment of the container, the container is at
least partially implemented from a resilient material. For example,
referring to the U-shape, at least one leg or the area between the legs
may be resilient.

[0034] It is found that the container may be advantageously manufactured
from a resilient material, such as a biocompatible rubber or the like.
Preferably, the container is molded, which enables its simple production.

[0035] In a still further embodiment of the container, the at least one
region for accommodating an electronic device comprises a cavity for
receiving said device.

[0036] In a still further embodiment of the container, the container is
provided with a projection, cavity or a rim for enabling handling of the
container.

[0037] It is found to be particularly advantageous to provide the
container with an element which can be engaged by a medical specialist
while inserting it in the lower jaw. Due to the fact that the container
is usually handled using tweezers, engagement with such element may
reduce a tissue damage hazard compared to a situation when the container
is to be handled by engaging its outer surface.

[0038] In a still further embodiment of the container it further comprises
at least one cavity for enabling positioning of the container using
vacuum suction.

[0039] It is found that positioning of the container in the lower jaw may
be improved when vacuum suction is used. For this purpose the container
may be provided with a suitable cavity conceived to cooperate with an
external pump for vacuum positioning the container in the space of the
lower jaw.

[0040] In a still further embodiment of the container, it further
comprises a safety element for enabling an acute removal of the container
from said space.

[0041] Preferably, the safety element is a cord which may be pulled for
acutely removing the container from the oral cavity. Preferably, the cord
comprises an indicator for indicating a position of the container and/or
a condition of the electronic device. This has an advantage that a
position and/or the condition of the monitor may be easily assessed from
the outside without disrupting the monitoring sequence.

[0042] These and other aspects of the devices and methods described will
be discussed in further detail with reference to drawings, wherein like
reference numerals represent like elements. It will be appreciated that
the drawings are presented for illustrative purposes and may not be used
for limiting the scope of the appended claims. It will be further
appreciated that while these exemplary embodiments are being discussed
with reference to the U-shape they may be implemented on other shapes,
such as O-shape and the arc-shape as well.

BRIEF DESCRIPTION OF THE DRAWINGS

[0043]FIG. 1 presents in a schematic way embodiments of the container.

[0044]FIG. 2 presents in a schematic way an embodiment of an outer slope
of the container.

[0045]FIG. 3 presents in a schematic way a further embodiment of the
container.

DETAILED DESCRIPTION OF THE DRAWINGS

[0046]FIG. 1 presents in a schematic way embodiments of the container 10.
In view 10a a top view of the container is shown. It will be appreciated
that although the container 2 is depicted as a U-shape, other shapes are
possible, like an O-shape an arc-shape or the like. It will be
appreciated that in case the O-shape is used the container may be
compressed by exercising a lateral force on the body of the O-shape at a
desired position. The container 2 according to an aspect of the invention
may comprise legs L1, L2 at least one which may be displaceable as is
indicated by the arrows R1, R2. Accordingly, when the container is to be
positioned inside the lower jaw of the recipient, it may be compressed by
urging the one or two legs towards the symmetry axis of the U-shape (not
shown). As a result handling of the container is improved. It will be
appreciated that the container 10a may be handled by hand or using
tweezers or any other suitable instrument. Preferably, for handling
purposes the container is provided with a grip element, like a rim 8
shown in view 10c, a projection (not shown) or a cavity. For example, for
this purpose it is also possible to use the prefabricated cavities 3a,
3b, 3c conceived to accommodate an electronic device for positioning
purposes. Before or after positioning is completed, the cavities may be
filled with desired electronics. Preferably, a temperature sensor, a
photoplethysmograph or any other suitable device is provided in the
cavities 3a, 3b or 3c. Those skilled in the art of intra-oral monitoring
will readily appreciate what kind of electronic devices may be positioned
inside the container. It will be appreciated, however, that a suitable
stimulating device, for example an electrode-based stimulator may also be
positioned in the container instead of, or next to a suitable monitor.

[0047] Alternatively or additionally, the electronic device may relate to
a miniature pump, for example a squiggle pump, which may be used to
collect a suitable volume of saliva for analysis. This technical measure
is based on the insight that saliva comprises sufficient concentration of
markers which may be a good indicator of physiologic condition of the
patient. It will be further appreciated that the electronic pump may be
provided in the intra-oral device of any shape and nature for enabling
suitable physiologic monitoring. Preferably, the saliva pump is provided
in the container. It will be further appreciated that a suitable
container may comprises one or more markers comprising suitable reagents
conceived to undergo a chemical reaction with a suitable trace element in
the saliva. Preferably, such marker is adapted to change color upon an
event a target trace element is detected. This embodiment is particularly
useful as it provides an immediate indication of the physiological
condition of the patient and does not require substantive laboratory
tests for analyzing collected saliva.

[0048] According to an aspect, an outer surface 5 of the container 2
comprises a soft and, preferably, flexible material. This feature enables
a better fixating of the container 2 in the space inside the lower jaw.

[0049] View 10b schematically depicts an embodiment of the container
according to a further aspect of the invention wherein the soft material
positioned at an outer surface of the container is shapeable on demand.
For example, a suitable bag 6 may be arranged on an outer surface of the
container. It will be appreciated that such bag may expand over the
entire outer surface or over a portion of the outer surface of the
container. The bag 6 may be filled with a suitable filling material, for
example foam balls 6a, which may be brought into a desired shape under
vacuum when the container is in place. This feature has an advantage that
an individually shaped container may be provided on demand which may
further improve accuracy of monitoring and user friendliness. For this
purpose the vacuum ports 4a, 4b may be provided which are arranged in
fluid communication with the bag 6. Alternatively or additionally the
ports 4a, 4b may be arranged as cavities for enabling positioning of the
container 2 in the lower jaw using vacuum suction.

[0050] View 10c schematically depicts a further embodiment of the
container wherein only two cavities for accommodating electronic devices
may be provided. It will be appreciated that one of the cavities may be
used as a utility cavity, suitably accommodating a power supply and/or
signal processing electronics, or wireless communication module.
Advantageously, necessary wiring is embedded in the material of the
container and runs from cavity 3a via the base portion to the cavity 3b.
Other wiring arrangements are possible as well.

[0051] Optionally, the container may comprise a safety element, like a
cord 9, which may be used for emergency handling of the container, for
example, when it is necessary to acutely remove the container from the
intra-oral cavity. Advantageously, the safety element 9 is provided with
suitable indicators 9a, 9b arranged to indicate that a position of the
container is as desired and/or whether electronics functions properly. It
will be appreciated that a former indicator may be a mark or the like,
which the latter indicator may comprise an electronic means, like a LED
lamp or the like.

[0052] According to a further aspect, the container is dimensioned to a
length W between 25-30 mm (i.e. the distance between the base of the
U-shape and the distal portions of the legs). A width H of the U-shape
may be set to a value in the range of 32-36 mm, when at rest. Preferably,
a width of the compressed U-shape is 20-25 mm. It will be appreciated
that for an O-shaped container the dimensions may be similar.

[0053]FIG. 2 presents in a schematic way an embodiment of an outer slope
of the container. This view schematically indicates a cross-section of
the container 2 taken along the line A-A as indicated in FIG. 1.
Accordingly, the outer surface O of the container 2 may be provided with
a slope a for substantially matching an inner slope of the lower jaw
cavity. It will be appreciated that an average slope may be selected
based on clinical insights, or a set of containers may be provided each
having a slightly different slope.

[0054] In addition, to improve fixation of the container in the lower jaw
cavity, the outer surface of the container may be provided with a soft
shapeable material. For example, a bag 22 may be provided, which is
filled with suitable particles 22a. When the inner volume of the bag 22
is evacuated, the outer shape of the bag substantially conforms to the
inner shape of the lower jaw enabling individually shaped container. This
feature may still further improve functional features of the monitoring
device associated with the container as well as user friendliness of the
container. It will be further appreciated that in case when the shapeable
material is provided the slope of the outer surface may be substantially
right or even crossing the bottom portion B at an angle α>90
degrees. This feature provides supplementary space for shaping the bag
22. The cavity 31 may be used for accommodating a suitable electronic
meter or suitable supplementary equipment, like a power supply, a data
processing unit, or a communication module.

[0055]FIG. 3 presents in a schematic way a further embodiment of the
container 30. It will be appreciated that the container 30 may be
implemented according to any of the aspect discussed with reference to
FIG. 1 or 2. In addition or alternatively, a bottom portion of the
container 30, in the area between the legs 38 and 39, may be provided
with a fixation member 37 (shown in view 30a), which may comprise two
substantially thin layers of material (32, 34, shown in view 30b)
provided with a chamber 33 therebetween wherein a lower layer of material
is provided with perforations 35. Such fixation member may be used to
fixate the container 30 against a bottom portion of the lower jaw of the
patient under action of a vacuum pump 40 causing the chamber between
these layers to be evacuated. It is appreciate that such construction
causes generation of fixating force to the container 30 when the chamber
33 is at least partially evacuated. Preferably, for the bottom layer
and/or for the upper layer a foil is used.

[0056] It will be appreciated that although specific embodiments of the
structure are discussed separately for clarity purposes,
interchangeability of compatible features discussed with reference to
isolated figures is envisaged. While specific embodiments have been
described above, it will be appreciated that the invention may be
practiced otherwise than as described. The descriptions above are
intended to be illustrative, not limiting. Thus, it will be apparent to
one skilled in the art that modifications may be made to the invention as
described in the foregoing without departing from the scope of the claims
set out below.

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